Issued on behalf of AVAI Bio, Inc.
LAS VEGAS, Sept. 08, 2026 (GLOBE NEWSWIRE) — Biotech Insider News Commentary - Type 1 diabetes has an unusual property among serious diseases: the science of curing it is largely solved.
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science → issue → it
Put working insulin-producing beta cells back into a person, and their body will begin to regulate glucose again.
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body → put → glucose
It has been demonstrated in humans, repeatedly, with patients coming off insulin entirely.
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patients → demonstrate → insulin
The obstacle is not whether replacement cells work.
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cells → work → ?
It is that the immune system destroys them, and the drugs that stop the immune system from doing so carry costs of their own.
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that → destroy → own
Companies mentioned in today’s commentary include: Avaí Bio, Inc. (OTCQB: AVAI), Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX), and Sana Biotechnology, Inc. (Nasdaq: SANA).
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Companies → mention → Bio
The cure works, but only under the cover of immunosuppression.
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cure → work → immunosuppression
In a published trial of a stem cell-derived islet therapy, all 12 patients regained insulin production and ten of the twelve stopped using injected insulin entirely.
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ten → publish → insulin
Every one of them requires chronic immunosuppressive drugs to keep those cells alive.
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one → require → cells
Three approaches are competing to remove that requirement.
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approaches → compete → requirement
Accept the immunosuppression and improve it, gene-edit the cells so the immune system does not see them, or physically wall the cells off inside a capsule.
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system → accept → capsule
All three are currently being pursued, by different companies, with different risk profiles.
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three → pursue → profiles
On August 12, 2026, its joint venture Insulinova signed a Research and Option Agreement with Ospedale San Raffaele in Milan to combine OSR’s stem cell-derived beta cells with Austrianova’s Cell-in-a-Box® encapsulation technology.
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venture → sign → technology
The program will be led by Professor Lorenzo Piemonti, Director of the Diabetes Research Institute at OSR, along with Dr. Valeria Sordi, Head of its Beta Cell Differentiation Unit.
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program → lead → Unit
Insulinova funds the work and supplies the encapsulation equipment and materials.
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Insulinova → fund → equipment
No trial has been announced, no regulatory pathway has been disclosed, and no timeline was given.
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timeline → announce → ?
The question being tested is whether encapsulated beta cells survive and function while being shielded, which is exactly the question the field has not yet answered.
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field → test → ?
It keeps people alive, and modern pumps and continuous monitors have made it far better than it was, but it does not restore the thing that was lost.
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that → keep → thing
A healthy pancreas adjusts insulin continuously, in response to glucose, without the person thinking about it.
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person → adjust → it
Injected insulin approximates that with a lag, and the consequences of getting the dose wrong run from unpleasant to fatal.
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dose → inject → lag
Beta cell replacement attacks the actual deficit.
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replacement → attack → deficit
Transplanting islet cells that sense glucose and secrete insulin on demand restores the feedback loop rather than imitating it.
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that → transplant → it
Donor islet transplantation has existed for years and proved the concept, but it has always been limited by supply, because cadaver pancreases are scarce, and by the same immune problem that limits everything else in this field.
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that → exist → field
Stem cell-derived islets solved the supply problem.
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islets → derive → problem
Manufacturing insulin-producing cells from a renewable stem cell line means the constraint is production capacity rather than organ donors.
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constraint → manufacture → line
That change is what moved beta cell replacement from a niche procedure for the most severe cases toward something that could, in principle, be offered broadly.
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that → move → principle
What it does not solve is rejection.
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solve → solve → What
The immune system in a person with Type 1 diabetes has already destroyed their own beta cells once.
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system → destroy → cells
Introducing new ones, from any source, invites it to do so again, and to treat the transplant as foreign tissue on top of that.
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Introducing → introduce → that
Which leaves the field with one question and three answers.
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Which → leave → question
Approach One: Accept the Immunosuppression
The furthest advanced approach takes the drugs as the price of entry.
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approach → accept → entry
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported data from the Phase 1/2 portion of its FORWARD trial of zimislecel, formerly VX-880, an allogeneic stem cell-derived, fully differentiated islet cell therapy infused into the hepatic portal vein.
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Incorporated → report → vein
Among 12 patients with Type 1 diabetes and impaired hypoglycemic awareness followed at least a year, all 12 showed restored insulin secretion measured by C-peptide.
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12 → impair → peptide
The rest of the result is what made it notable.
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it → make → result
All 12 stopped having severe hypoglycemic events.
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12 → stop → events
All met glycemic control targets of A1C below 7% and time in range above 70%.
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All → meet → %
Exogenous insulin use fell by an average of 92%, and ten of the twelve came off insulin altogether.
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ten → fall → insulin
The data were presented at the American Diabetes Association annual meeting and published in the New England Journal of Medicine.
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data → present → Medicine
Zimislecel requires chronic immunosuppressive therapy to protect the transplanted cells from rejection.
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Zimislecel → require → rejection
That is a real cost: infection risk, kidney effects, cancer risk over time, and a lifelong drug regimen traded for a lifelong insulin regimen.
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That → trade → regimen
…and 89 more, not listed.
